Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy
Treatment of Polypoidal Choroidal Vasculopathy With Ranibizumab(Lucentis): A Phase I/II Safety Study.
1 other identifier
interventional
20
1 country
1
Brief Summary
This Phase I/II safety study is designed to investigate the safety and efficacy of ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. These abnormal blood vessels can bleed or leak fluid, causing disruption of normal retinal function and vision loss. Ranibizumab is a drug that is FDA-approved for the treatment of wet age-related macular degeneration (AMD) and is injected directly into the eye. Given the efficacy of ranibizumab in the treatment of wet AMD, and the postulated similarity between the disease mechanisms involved in both wet AMD and PCV, we believe ranibizumab will have a beneficial effect on visual function in patients with PCV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2006
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
June 23, 2014
CompletedApril 16, 2019
April 1, 2019
4.6 years
February 4, 2009
November 3, 2011
April 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Commonly Reported and Notable Adverse Events
Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.
2 years
Study Arms (2)
Ranibizumab 0.5 mg/ 0.05 cc
EXPERIMENTALIntraocular injection of 0.5 mg/ 0.05 cc ranibizumab
Ranibizumab 0.3 mg/ 0.05 cc
EXPERIMENTALIntraocular injection of 0.3 mg/ 0.05 cc ranibizumab
Interventions
ranibizumab 0.5 or 0.3 mg/0.05 cc administered intraocularly on a monthly basis for 3 months, followed by monthly examination with the option of further ranibizumab treatment or other therapies at the discretion of the treating physician
Eligibility Criteria
You may qualify if:
- Age \>35 years
- Exudative, active PCV in 1 eye.
- PCV is defined as choroidal neovascularization that displays occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography.
You may not qualify if:
- Age \<35 years
- Prior treatment with non-ranibizumab therapies (e.g., laser, surgery, or bevacizumab)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Southeast Retina Center, Georgialead
- Genentech, Inc.collaborator
Study Sites (1)
Southeast Retina Center
Augusta, Georgia, 30909, United States
Related Publications (1)
Marcus DM, Singh H, Lott MN, Singh J, Marcus MD. Intravitreal ranibizumab for polypoidal choroidal vasculopathy in non-Asian patients. Retina. 2013 Jan;33(1):35-47. doi: 10.1097/IAE.0b013e3182618be0.
PMID: 22990319DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Dennis M Marcus Principal Investigator
- Organization
- Southeast Retina Center, P.C.
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis M. Marcus, M.D.
Southeast Retina Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Dennis M. Marcus Principal Investigator
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 5, 2009
Study Start
May 1, 2006
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 16, 2019
Results First Posted
June 23, 2014
Record last verified: 2019-04